Impact of an Intervention Program on Parenting Stress After Preterm Birth

NCT ID: NCT02394444

Last Updated: 2015-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2010-02-28

Brief Summary

The aim of this study was to assess the impact of an early psychological intervention, Triadic parent-infant Relationship Therapy (TRT), on parenting stress, parental mental health, and preterm infant development in the motor, cognitive, emotional and behavioral domains at a corrected age of 18 months.

Detailed Description

Due to prematurity induced infant-mother separation at birth, sometimes for several weeks, and owing to the concerns it generates, preterm birth exposes the parent-child attachment link to disturbances, especially the mother-child attachment after discharge. Several psychological factors affect infant (distress, dysmaturity ) and parents (psychological pain). These can cause lasting parent-child interactions disruption and jeopardize the attachment process. These early link distortions may hinder the infant's behavioral-emotional and cognitive development. Prematurity psychological consequences may negatively influence biomedical risks. Understanding these premature infants' future development modalities and support involves taking into account intricate organic and psychological factors - which may be combined as well.

Post-hospital psychological intervention with the family, focusing on parental mental health and triadic parent-infant relationship, proves an essential element in these children care, whose birth conditions were painful.

Conditions

Preterm Birth; Parenting; Mental Health Wellness 1; Parent-Child Relation; Child Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Preterm intervention TRT group

Parents with premature infants received the intervention called "Triadic parent-infant's Relationship Therapy" (TRT) :

the psychological intervention included home visits twice month during the first four months and then monthly visits in the neonatal ward until the 18 months corrected age resulting in a total of 22 visits during the whole intervention; TRT gave attention to emotional distress and the promotion of parenting skills and attachment security; The three sessions of intervention targeted objectives specific to each child's development; A basic manual was designed to ensure uniformity of the defined themes during each session

Group Type: EXPERIMENTAL

Triadic parent-infant Relationship Therapy (TRT)

Intervention Type: OTHER

22 sessions, including home visits twice per month during the first four months, followed by monthly consultations in the neonatology ward, up to corrected age of 18 months.

Preterm control group

Parents with premature infants without intervention program TRT (Triadic parent-infant's Relationship Therapy) received routine follow-up medical care with monthly visits to a practitioner for the first six months and then very three months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Full-term control group

Parents with full-term infants without intervention program TRT

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Triadic parent-infant Relationship Therapy (TRT)

22 sessions, including home visits twice per month during the first four months, followed by monthly consultations in the neonatology ward, up to corrected age of 18 months.

Intervention Type: OTHER

Other Intervention Names

TRT

Eligibility Criteria

Inclusion Criteria

• Enrolled preterm infant were required to be between 28 and 35 weeks gestational age +6 days
• Enrolled the parents were required to be French speakers, over 18 years old and residing within 50-kilometres radius of hospital

Exclusion Criteria

• preterm infant without congenital anomalies or any other foreseeable disabilities during the neonatal period
• parents without known psychiatric history

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 35 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernard Guillois, PhD

Role: PRINCIPAL_INVESTIGATOR

Neonatology Department, Hospital and university center, Caen

Sophie Castel, MD

Role: PRINCIPAL_INVESTIGATOR

Neonatology Department, Hospital and university center, Caen

References

Guillois B, Castel S, Beunard A, Blaizot X, Creveuil C, Proia-Lelouey N. [Effect of early intervention programs on neurobehavioral outcome in premature infants after discharge]. Arch Pediatr. 2012 Sep;19(9):990-7. doi: 10.1016/j.arcped.2012.06.004. Epub 2012 Aug 9. French.

Reference Type: BACKGROUND

PMID: 22884746 (View on PubMed)

Sizun, J., Guillois, B., Casper, C., Thiriez, G., Kuhn, P. 2014.Soins de développement en période néonatale.De la recherche à la pratique. Springer.

Reference Type: BACKGROUND

This study was submitted at the 52nd Annual Meeting of the European Society for Pediatric Research at Newcastle (october 15-17th 2011)

Reference Type: BACKGROUND

This study was presented in Communication at the 42nd Journées Nationales de Néonatologie in Paris, march 2012.

Reference Type: BACKGROUND

Other Identifiers

2006/0215

Identifier Type: REGISTRY

Identifier Source: secondary_id

2005-36

Identifier Type: REGISTRY

Identifier Source: secondary_id

05-094

Identifier Type: -

Identifier Source: org_study_id